Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S074 |
Date Received | 02/02/2021 |
Decision Date | 03/03/2021 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Introduction of Lifecore Biomedical, LLC Site 2 as a additional quality control laboratory for release and stability chemistry testing of the VISCOAT and PROVISC Ophthalmic Viscosurgical Devices, as well as the DUOVISC Ophthalmic Viscoelastic System. |
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